Phase
Condition
Rheumatoid Arthritis
Joint Injuries
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients, >/= 18 years of age
Active rheumatoid arthritis (DAS28-ESR > 3.2), according to the revised (1987) ACRcriteria or EULAR/ACR (2010) criteria of > 6 months duration
Patients with intolerance or inadequate response to methotrexate or other non-biologicDMRADs or inadequate response to a first ant-TNF agent
Oral corticosteroids (</= 10 mg/day prednisone or equivalent) and non-steroidalanti-inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted ifon a stable dose regimen for >/= 4 weeks prior to baseline
Permitted non-biologic DMRAD is allowed if at stable dose for at least 4 weeks priorto baseline
Females of childbearing potential and males with female partners of childbearingpotential must be using a reliable means of contraception as defined by protocolduring the study and for at least 3 months following the last dose ofRoActemra/Actemra
Patients with intolerance or inadequate response to methotrexate or other non-biologicDMARDs or inadequate response to first anti-TNF agent
Exclusion
Exclusion Criteria:
Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following baseline
Rheumatic autoimmune disease other than RA or significant systemic involvementsecondary to RA; secondary Sjögren's syndrome with RA is permitted
Functional Class IV as defined by the ACR Classification of Functional Status inRheumatoid Arthritis
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Prior history of current inflammatory joint disease other than RA
Exposure to tocilizumab (either intravenous [IV] or SC) at any time prior to baseline
Treatment with any investigational agent with four weeks (or five-half lives of theinvestigational drug, whichever is longer) of screening
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
Previous treatment with Abatacept
History of severe allergic of anaphylactic reactions to human, humanized, or murinemonoclonal antibodies
Evidence of serious uncontrolled concomitant cardiovascular, nervous system,pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disease
History of diverticulitis, diverticulitis requiring antibiotic treatment, or chroniculcerative lower GI disease such as Crohn's disease, ulcerative colitis, or othersymptomatic lower GI conditions that might predispose to perforation
Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,or other infections (including but not limited to tuberculosis [TB] and atypicalmycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungalinfections or nail beds)
Any major episode of infection requiring hospitalization or treatment with IVantibiotics within 4 weeks of screening or oral antibiotics within 2 weeks ofscreening
Active TB requiring treatment within the previous 3 years
Positive hepatitis B or hepatitis C
Primary or secondary immunodeficiency (history of or currently active)
Evidence of active malignant disease, malignancies diagnosed with the previous 10years (including hematological malignancies and solid tumors, except basal of squamouscell carcinoma of the skin diagnosed within the previous 20 years
Pregnant and lactating women
History of alcohol, drug, or chemical abuse within 1 year prior to screening
Neuropathies or other conditions that might interfere with pain evaluation
Inadequate hematological, real of liver function
Study Design
Connect with a study center
Co Leitrim,
IrelandSite Not Available
Cork,
IrelandSite Not Available
Dublin, 24
IrelandSite Not Available
Dublin 4, 4
IrelandSite Not Available
Limerick, 0
IrelandSite Not Available
Waterford,
IrelandSite Not Available
Almada, 2801-951
PortugalSite Not Available
Amadora, 3814-501
PortugalSite Not Available
Lisboa, 1649-035
PortugalSite Not Available
Porto, 4200-319
PortugalSite Not Available
Elche, Alicante 03203
SpainSite Not Available
Merida, Badajoz 06800
SpainSite Not Available
Sabadell, Barcelona 08208
SpainSite Not Available
Sant Joan Despi, Barcelona 08970
SpainSite Not Available
Terrassa, Barcelona 08221
SpainSite Not Available
Jerez de La Frontera, Cadiz 11407
SpainSite Not Available
Torrelavega, Cantabria 39300
SpainSite Not Available
San Sebastian, Guipuzcoa 20080
SpainSite Not Available
Palma de Mallorca, Islas Baleares 07198
SpainSite Not Available
La Coruna, La Coruña 15006
SpainSite Not Available
Santiago De Compostela, La Coruña 15706
SpainSite Not Available
Las Palmas de Gran Canaria, Las Palmas 35016
SpainSite Not Available
Fuenlabrada, Madrid 28942
SpainSite Not Available
Cartagena, Murcia 30203
SpainSite Not Available
El Palmar, Murcia 30120
SpainSite Not Available
empty
Ourense, Orense 32005
SpainSite Not Available
Valenica, Valencia 46009
SpainSite Not Available
Bilbao, Vizcaya 48013
SpainSite Not Available
Alicante, 03010
SpainSite Not Available
Barcelona, 08036
SpainSite Not Available
Burgos, 06006
SpainSite Not Available
Cordoba, 14004
SpainSite Not Available
Granada, 18014
SpainSite Not Available
Guadalajara, 19002
SpainSite Not Available
Madrid, 28905
SpainSite Not Available
Malaga, 29009
SpainSite Not Available
Salamanca, 37007
SpainSite Not Available
Sevilla, 41013
SpainSite Not Available
Tarragona, 43700
SpainSite Not Available
Tenerife, 38010
SpainSite Not Available
Toledo, 45004
SpainSite Not Available
Valencia, 46010
SpainSite Not Available
Zaragoza, 50009
SpainSite Not Available
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